The word validation has several uses: In general, validation is the process of checking if something satisfies a certain criterion. Examples would include checking if a statement is true (
validity), if an appliance works as intended, if a
computer system is secure, or if computer
data are compliant with an
open standard. Validation implies one is able to testify that a solution or process is correct or compliant with set
standards or
rules. In a
quality management system, validation should not be confused with
verification. Validation usually relates to meeting the needs of an external customer or user of a product, service, or system: Verification is usually an internal
quality process of determining compliance with a regulation or
specification. An easy way of recalling the difference between
validation and verification is that validation is ensuring "you built the right product" and verification is ensuring "you built the product right." Verification is testing to confirm that a product complies with its requirements and specifications. Validation is testing to confirm that it satisfies stakeholder needs.Validation can mean to declare or make legally valid or to prove valid or confirm the validity of data, information, or processes:
Validation of foreign studies and degrees.In computer terminology, validation refers to the process of
data validation, controlling that data inserted into an application satisfies pre determined formats or complies with stated length and character requirements and other defined input criteria. In
computer security, validation also refers to the process of verifying that a
user or
computer program is allowed to do something. In
psychology and
human communication, validation is the reciprocated communication of respect which communicates that the other's opinions are acknowledged, respected, heard, and (regardless whether or not the listener actually agrees with the content), they are being treated with genuine respect as a legitimate expression of their feelings, rather than marginalized or dismissed.In the pharmaceutical and biotechnology industry,
validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes (from European Union
Good Manufacturing Practices Guide, Annex 15). Regulatory bodies in the U.S., European Union, and Japan (amongst many others)
require validation, causing it to become its own sub-industry supporting the pharmaceutical, biotechnology, and medical device industries.in finance, validation is a process part of the "trade life-cycle."Validation is important because it disallows data that can not possibly be either true or real to be entered into a database or computer system.Validation against an incomplete or insufficient set of criteria can lead to a state of "validated" where "validated" does not confer the confidence that the term intends. Thus validation of the validation criteria is an important aspect that is often overlooked. Establishing such validation criteria can be a very difficult task when evaluating complex systems such as Air Traffic Management systems. Establishing "fitness for purpose" is often a more useful concept to support evaluation of complex systems in that the approach focuses on involving stakeholders in establishing and reviewing the purpose that the system must satisfy as the system emerges from early design. This allows flexibility in the evaluation process as ideas turn into detailed designs. Such flexibility is essential in the early development phases in order to avoid engineering
white elephants. [The European Operational Concept Validation Methodology E-OCVM provides an approach to validating complex Air Traffic Management systems by establishing fitness for purpose in a world of shifting and incomplete validation criteria]
E-OCVM.
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